Quality Assurance Coordinator - Remote | Wfh

We are seeking a passionate and dedicated Quality Coordinator to join our team. In this role, you will play a vital part in ensuring our commitment to excellence and adherence to quality standards, both internally and externally. If you have a strong background in quality assurance, are detail-oriented, and possess excellent communication skills, we would love to hear from you.
Main Responsibilities
Complaint Handling: Manage the complaint handling process and actively participate in MDR forums.
Training: Compile, create, and deliver training materials on quality standards and activities as necessary.
Quality Alerts: Initiate and maintain the Quality Alert process to ensure prompt response to quality issues.
Reporting: Regularly report to management for periodic reviews, including QRC and Management Review as needed.
Quality Control: Conduct quality activities to ensure product controls and adherence to protocols and specifications, supporting our commitment to Quality Assurance.
Continuous Improvement: Support the implementation of process and product improvements within the Quality Management System.
Continuous Improvement: Embrace a culture of continuous improvement and actively contribute to it.
Audits and Inspections: Support audits and inspections as required, demonstrating our commitment to quality.
Trend Analysis: Establish routine trend analysis to drive informed decision-making.
Other Duties: Perform other duties as assigned to support the team and our quality goals.
Competencies
Proficiency in computer skills, including MS Word, MS Excel, and familiarity with ERP systems.
Strong attention to detail and a commitment to maintaining high-quality standards.
Excellent communication and collaboration skills to effectively work with cross-functional teams.
Problem-solving abilities to address challenges effectively.
Capacity to work under pressure with multiple deadlines while maintaining composure.
Proficient understanding of written and verbal English.
Reporting Relationships And Supervision
This position reports directly to the Senior Manager of Quality Assurance and does not have any direct reports.
Education And Experience
Associate Degree in a related scientific or engineering technology field, or an equivalent combination of education, training, and experience.
Proficiency in computer applications, including Microsoft Excel, PowerPoint, and Word.
A minimum of 3 years of experience in a regulated industry.
A working knowledge of domestic and international medical device regulatory requirements (FDA, ISO-13485, MDD 93/42/EEC, Health Canada regulations, etc.) is preferred.
We encourage you to apply if you're a dedicated quality professional looking to make a significant impact in a dynamic and collaborative environment. Join us in our pursuit of excellence and continuous improvement. We look forward to welcoming you to our team!
Salary: $ 42,080.00 52,600.00 Per Year